Rhizen Pharmaceuticals S.A., an nounced that the U.S. Food and Drug Administration (FDA) has granted orphan - drug designation for the active moiety of Tenalisib (RP6530), the Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, for treatment of peripheral T - cell l ymphoma (PTCL).
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“We are pleased to receive US FDA orphan - drug designation for the active moiety of Tenalisib (RP6530), our Company’s highly selective and orally active dual PI3K delta/gamma inhibitor, and we look forward to advancing the drug into further develop ment for treatment of peripheral T - cell l ymphoma ( PTCL),” said Swaroop Vakkalanka, Ph.D., Founder & President of Rhizen Pharmaceuticals S.A.
Tenalisib ( RP6530 ) is a highly selective and orally active dual PI3K delta/gamma inhibitor with efficient translation of activity through e nzyme, cell, and whole blood - based studies. Besides inhibiting growth of immortalized cancerous cell lines and primary patient leukemic/lymphoma cells, RP6530 plays a significant role in modulation of tumor microenvironment at clinically achievable concen trations. In preclinical studies, RP6530 reprograms macrophages from an immunosuppressive M2 - like phenotype (pro - tumor) to an inflammatory M1 - like state (anti - tumor), which can potentially enhance the ac tivity of checkpoint inhibitors or overcome resistan ce to these drugs. Tenalisib obtained US FDA Fast Track and Orphan - Drug Designation s for tr eatment of peripheral T - cell lymphoma (PTCL).
